BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3192277 · Received June 27, 2013

    Report

    Report Number
    3002648230-2013-00099
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. VISUAL INSPECTION SHOWED THAT THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION SHOWED THAT THE CATHETER WAS USED FOR 7 INJECTIONS. THE CATHETER PASSED THE PERFORMANCE TEST AND THE ELECTRICAL INTEGRITY AS PER SPECIFICATION, ALSO THE IMPEDANCE WAS WITHIN SPECIFICATION. THE DISSECTION / PRESSURE TEST DID NOT SHOW ANY LEAK OR TRACES OF LIQUID, BLOOD INSIDE THE CATHETER. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    ROUTINE PULMONARY VEIN ISOLATION PROCEDURE WITH NORMAL LA ANATOMY. BASELINE PATIENT BLOOD PRESSURE RANGED FROM 75-100/50. TEE PERFORMED PRIOR TO CASE START CONFIRMED NO VISIBLE THROMBUS AND NO PERICARDIAL EFFUSION. FOLLOWING ABLATION #4 (SECOND ABLATION OF LIPV), THERE WAS AN ABRUPT DROP IN PATIENT'S BLOOD PRESSURE. ICE WAS UTILIZED TO INSPECT THE PERICARDIUM. THE PHYSICIAN CONFIRMED THE PRESENCE OF A PERICARDIAL EFFUSION WHICH HE CLASSIFIED AS SMALL. PATIENT WAS MONITORED FOR A FEW MINUTES AND HEMODYNAMICS NORMALIZED SO PROCEDURE WAS CONTINUED. RIPV AND RSPV WERE ISOLATED AND FOLLOWING THE SECOND ABLATION IN THE RSPV, THE PATIENT'S BLOOD PRESSURE AGAIN DROPPED. AN ATRIAL TACHYCARDIA OCCURRED AND BECAME SUSTAINED JUST BEFORE THE BLOOD PRESSURE DROP. ANTI-TACHYCARDIA PACING AND CARDIOVERSION WERE EACH ATTEMPTED FOR CONVERSION OF RAPID ATRIAL TACHYCARDIA; HOWEVER, THESE WERE UNSUCCESSFUL AND/OR BRIEFLY SUCCESSFUL. THE PATIENT RAPIDLY DECOMPENSATED AND CHEST COMPRESSIONS WERE INITIATED DUE TO SEVERE HYPOTENSION. EMERGENCY PROTOCOLS WERE INITIATED AND AMIODARONE AND EPINEPHRINE WERE GIVEN AS WELL AS OTHER VASOPRESSORS. CHEST COMPRESSIONS CONTINUED TO BE PROVIDED INTERMITTENTLY. CATHETERS WERE REMOVED FROM THE LEFT ATRIUM. LABS WERE DRAWN. PROTAMINE WAS ADMINISTERED. ULTIMATELY, THE PHYSICIAN DECIDED TO PERFORM PERICARDIOCENTESIS. APPROXIMATELY 250CC OF BLOOD WAS REMOVED FROM THE PERICARDIUM. HEMODYNAMICS NORMALIZED SHORTLY AFTER THE INTERVENTION, ALTHOUGH THE ATRIAL TACHYCARDIA CONTINUED TO RECUR, CAUSING MODERATE DECOMPENSATION EACH TIME. THE PHYSICIAN APPLIED FOUR RF LESIONS (TO CS AND MID CRISTA TERMINALIS) AND THEN ENDED PROCEDURE. PATIENT WAS EXTUBATED IN THE ROOM AND AWOKE ORIENTED. DEVICE 2 OF 3, REFERENCE MFR REPORT: 3007798852-2013-00010, 3002648230-2013-00100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293064 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF234

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention FLEXCATH ADVANCE 4FC12, ACHIEVE 990063-015